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TAXUS II and IV: two-year follow-up

TAXUS II and IV: two-year follow-up. TAXUS IV Trial. TAXUS II Trial. 1,326 patients with single de novo lesions Lesions 10-28 mm in length, 2.5-3.75 mm in diameter; Double blind, randomized trial. 536 patients with single de novo lesions Lesions < 12 mm in length, 3.0-3.5 mm in diameter;

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TAXUS II and IV: two-year follow-up

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  1. TAXUS II and IV: two-year follow-up TAXUS IV Trial TAXUS II Trial 1,326 patients with single de novo lesions Lesions 10-28 mm in length, 2.5-3.75 mm in diameter; Double blind, randomized trial 536 patients with single de novo lesions Lesions <12 mmin length, 3.0-3.5 mm in diameter; Double blind, randomized trial • Paclitaxel-eluting stent • Slow-release formulation • n=662 • Paclitaxel-eluting stent • Slow-release formulation • n=131 • Moderate-release formulation • n=135 • Bare Stent • n= 652 • Bare Stent • n= 270 (combined control) • Endpoints (2 year follow-up): • TAXUS II – MACE (97% two-year clinical follow-up) – Late loss (<40% two-year angiographic follow-up) • TAXUS IV – MACE – angiographic results not presented Presented at TCT 2004

  2. TAXUS II: Late loss at 6 mo. and two yrs. Two-year angiographic results were available for < 40% of the original TAXUS cohorts, but those available showed little change in late-loss between six months and two years. p=<0.0001 p =NS p =NS mm TCT 2004

  3. TAXUS II: MACE at two years Target lesion revascularization (TLR) and target vessel revascularization (TVR) remained significantly lower in the TAXUS groups, resulting in lower overall MACE. p=0.0178 p=0.0178 p=0.0622 p=0.0126 % p=0.0047 p=0.0006 TCT 2004

  4. TAXUS II: MACE at two years (contin.) Despite reduced TLR and TVR in the TAXUS groups, CABG, MI, and death rates were not statistically different between the TAXUS and control groups. p=NS p=NS p=NS p=NS % TCT 2004

  5. TAXUS IV: MACE at two years TAXUS IV showed similar two-year results: TVR, TLR, and overall MACE remained significantly lower in the TAXUS group. p =<0.0001 p=<0.0001 p =<0.0001 % TCT 2004

  6. TAXUS IV: MACE at two years (contin.) Again, despite reduced overall MACE, rates of death and MI were not significantly different between the two groups. p =NS p=NS % TCT 2004

  7. TAXUS II and IV: two-year follow-up • Among patients with single de novo coronary lesions, treatment with a paclitaxel-eluting stent continued to be associated with a reduction in TLR and TVR at 2 years compared with bare stent • Consistent with the 6 month and 1 year data, TAXUS stents were not associated with a reduction in the clinical endpoints of death or MI at 2 years. • The on-going REALITY trial is a head-to-head trial comparing paclitaxel-eluting stents to sirolimus-eluting stents, which have also been associated with significant reduction in TVR (SIRIUS trial)

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